Human respiratory syncytial virus (RSV) is a common cause of upper respiratory tract illnesses as well as more severe lower respiratory illnesses, including bronchiolitis and pneumonia. RSV affects almost all children within the first 2 years of life. This study will evaluate the safety and immune response to the RSV MEDI ΔM2-2 vaccine among adults, RSV-seropositive children, and RSV-seronegative infants and children.

A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, RSV MEDI ΔM2-2 Lot RSV#002A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, RSV-Seropositive Children 12 to 59 Months of Age, and RSV-Seronegative Infants and Children 6 to 24 Months of Age

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Summarize the frequency of solicited adverse events (AEs) and other AEs [ Time Frame: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children ] [ Designated as safety issue: Yes ]

List the individual clinical solicited AEs and other AEs, graded by severity. These will be displayed in tabular format and stratified by group. [ Time Frame: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children ] [ Designated as safety issue: Yes ]

Where appropriate, chi-square or Fisher's exact test will be used to determine significant differences between groups [ Time Frame: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

List the peak titer and duration of virus shed by each individual participant. Data will be displayed in tabular format. Mean peak titer and mean duration of shedding will be calculated. [ Time Frame: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children ] [ Designated as safety issue: No ]

List the RSV antibody titer pre- and post-vaccination for each individual participant. Data will be displayed in tabular format. Mean antibody titers will be determined. [ Time Frame: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children ] [ Designated as safety issue: No ]

Determine the infectivity of the vaccine, defined as the proportion of vaccinees who either shed vaccine virus and/or had a fourfold or greater rise in serum antibody titer following vaccination [ Time Frame: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children ] [ Designated as safety issue: No ]

Where appropriate, the Mann-Whitney U test or Tukey-Kramer multiple comparison post-test will be used to determine significant differences between groups [ Time Frame: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children ] [ Designated as safety issue: No ]

Seronegative infants and children will receive one dose of the placebo vaccine intranasally.

Biological: Placebo vaccine

Given intranasally once at a baseline study visit

Detailed Description:

The purpose of this study is to evaluate the safety and immune response of the RSV MEDI ΔM2-2 vaccine in the four groups of participants. The study vaccine will be evaluated in adults, in RSV-seropositive children, and in a dose-ranging study in two groups of RSV-seronegative infants and children.

Willing to participate in the study as evidenced by signing the informed consent document

Female participants of childbearing potential must have negative urine pregnancy tests and must agree to use effective birth control methods (e.g., birth control pills, diaphragm and foam, condoms with spermicide, Depo-Provera) until 28 days after vaccination

Lung or heart disease, including any wheezing event or reactive airway disease. People with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. People who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.

Member of a household that includes an immunocompromised individual or infants younger than 6 months of age, other than a study participant

Attends day care with infants younger than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Note: children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.

Inclusion Criteria for Seronegative Infants and Children:

Healthy children 6 to 24 months of age whose parents/guardians can understand and sign the informed consent and agree to vaccine administration following detailed explanation of the study

Seronegative for RSV antibody, defined by serum RSV neutralizing antibody titer less than 1:40 determined within 30 days prior to inoculation

Person's history has been reviewed and they have undergone a physical examination indicating that s/he is in good health

Lung or heart disease, including any wheezing event or reactive airway disease. People with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. People who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.

Member of a household that includes an immunocompromised individual or infants younger than 6 months of age, other than a study participant

Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.

Temporary Exclusion Criteria for All Participants:

The following are temporary or self-limiting conditions and, once resolved, the person may be enrolled, if otherwise eligible. If the period of temporary exclusion is more than 56 days for adults or more than 30 days for RSV-seronegative children, the person will need to be rescreened. If the period of temporary exclusion is more than 56 days for RSV-seropositive children, a pre-inoculation serum antibody will need to be collected.

Fever (adult oral temperature of greater than or equal to 100.4°F [38°C] or pediatric rectal temperature of greater than or equal to 100.4°F [38°C]), or upper respiratory illness (rhinorrhea, cough, or pharyngitis), or nasal congestion significant enough to interfere with successful vaccination, or otitis media

Has received any killed vaccine or live attenuated rotavirus vaccine within the 2 weeks prior to study entry, any other live vaccine within the 4 weeks prior to study entry, or gamma globulin (or other antibody products) within the 3 months prior to study entry

Has received another investigational vaccine or investigational drug within 28 days of receiving this investigational RSV vaccine

Has received antibiotics or systemic or nasal steroid therapy for acute illness within the 3 days prior to vaccination (steroid skin creams or lotions and topical antibiotics or antifungal preparations are permitted)

Infant or child participant has received salicylate (aspirin) or salicylate-containing products within the 1 month prior to study entry

Infants born at less than 37 weeks gestation and less than 1 year of age

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459198